Cleared Special

NAVIJECT SUB2-1P, MODEL: LP604430

K092023 · Medicel AG · Ophthalmic
Jul 2009
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K092023 is an FDA 510(k) clearance for the NAVIJECT SUB2-1P, MODEL: LP604430, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Medicel AG (Hasbrouck Heights, US). The FDA issued a Cleared decision on July 28, 2009, 22 days after receiving the submission on July 6, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K092023 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2009
Decision Date July 28, 2009
Days to Decision 22 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MSS — Folders And Injectors, Intraocular Lens (iol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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